Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis (AMINOPOUCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02084550
Recruitment Status : Active, not recruiting
First Posted : March 12, 2014
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
Anders Mark Christensen, Aarhus University Hospital

Brief Summary:

The detrimental effects of catabolism, insuline resistance and muscle wasting on surgical outcome is wellknown. This catabolism is especially pronounced in patients with acute or chronic inflammation (IBD, cancer) and for those undergoing major surgery. Patients with ulcerative colitis operated with an ileal pouch-anal anastomosis (j-pouch) fall well into both these categories.

To prevent this undesirable catabolism, we will investigate the effects of intravenous administration of predominantly anabolic amino acids (with an amino acid content equal to breast milk) on whole body metabolism, with special emphasis on muscle and fat metabolism and intracellular signalling pathways.

Twenty-four patients will be block-randomized by gender in this parallel-group, randomized, assessor-blinded, placebo-controlled trial to receive either Vaminolac® (Fresenius Kabi) or saline. Metabolism before and after the intervention will be assessed by palmitate- and amino acid kinetics of radioactively labelled tracers, while muscle and fat biopsies will be analyzed for differences in intracellular signaling pathways (PI3 kinase, Akt, etc.) as a measure of cellular activity.

With this study we hope to find evidence for anabolic effects of intravenous amino acids in j-pouch surgery for ulcerative colitis. The perspective is a potential for primary prophylaxis of surgical complications, reduction in the length of hospitalization, and subsequently optimized long-term functional outcome of the pouch.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: Vaminolac Other: Saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial
Actual Study Start Date : September 2015
Actual Primary Completion Date : July 1, 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Vaminolac
Intravenous Vaminolac during 3 hours, with an infusion rate of 1,6ml/kilogram bodyweight/h.
Dietary Supplement: Vaminolac
Vaminolac with an amino acid content corresponding humane breast milk.

Placebo Comparator: Saline
Intravenous saline during 3 hours, with an infusion rate of 1,6ml/kilogram bodyweight/h.
Other: Saline
Intravenous isotonic saline with a sodium chloride content of 9mg/ml.

Primary Outcome Measures :
  1. Phenylalanine kinetics [ Time Frame: 6 hours ]

    Phenylalanine balance is determined by:

    PheBal = (PheA - PheV) x F

    Where PheBal is the phenylalanine balance (mg/L), PheA is the arterial concentration of phenylalanine, PheV is the venous concentration of phenylalanine, and F is the blood flow.

  2. Tyrosine kinetics [ Time Frame: 6 hours ]

    Tyrosine balance is determined by:

    TyrBal = (TyrA - TyrV) x F

    Where TyrBal is the tyrosine balance, TyrA is the arterial concentration of tyrosine, TyrV is the venous concentration of tyrosine, and F is the blood flow.

  3. Palmitate balance [ Time Frame: 5 hours ]
    Palmitate net balance will be estimated using blood flow and arterio-venous differenves in specific activity

Secondary Outcome Measures :
  1. Plasma changes in hormones and energy sources [ Time Frame: 6 hours ]
    Plasma changes in the levels of insulin, glucagon, catecholamines, cortisol, IGF[1], growth hormone, glycerol, urea, glucose

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with ulcerative colitis who are having an ileal pouch-anal anastomosis performed, 18 < age < 50, written informed consent.

Exclusion Criteria:

  • Inability to understand written Danish, postmenopause, severe asthma, diabetes mellitus, severe rheumatologic disease, severe comorbidity (ASA group III-IV) in general. Acute or progressing liver failure, uremia without possibility for dialysis, phenylketonuria, defects in amino acid metabolism. Participation in scientific studies in the preceding year, where ionizing radiation has been used, including significant x-ray investigations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02084550

Department of Surgery P, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Principal Investigator: Søren Laurberg, MD, DMSc Department of Surgery P, Aarhus University Hospital

Responsible Party: Anders Mark Christensen, PhD student, Aarhus University Hospital Identifier: NCT02084550     History of Changes
Other Study ID Numbers: 1-10-72-48-14
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Amino-acid, glucose, and electrolyte solution
Parenteral Nutrition Solutions
Pharmaceutical Solutions